NCT03799991 Vestibular Therapy in Alzheimer's Disease
| NCT ID | NCT03799991 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Johns Hopkins University |
| Condition | Vestibular Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2022-08-22 |
| Primary Completion | 2027-08-26 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2022-08-22 with a primary completion date of 2027-08-26.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Nearly 2 out of 3 patients with Alzheimer's disease (AD) experience problems with balance and mobility, which places such patients at increased risk of falling. The vestibular (inner ear balance) system plays an important role in balance stability, and vestibular therapy (VT) is well-known to improve balance function in healthy older adults. In this study, the investigators will conduct a first-in-kind randomized clinical trial to evaluate whether vestibular therapy improves reduces falls in patients with AD, in whom this treatment has never been studied.
Eligibility Criteria
Inclusion Criteria: * Diagnosis of AD based on the National Institute on Aging-Alzheimer Association 2011 criteria that is mild-moderate (CDR=0.5-2). * Age ≥ 60 years. * Vestibular loss defined as bilaterally impaired vestibular responses (semicircular canal or otolith responses). * Able to participate in study procedures including vestibular physiologic testing, balance and gait assessment, neurocognitive testing, and VT or active control. * Able to give informed consent, as further detailed in the Human Subjects section. The investigators anticipate that individuals who are too impaired to provide informed consent would also not be able to effectively participate in VT or active control. * Presence of a caregiver, defined as an individual who spends at least 10 hours per week with the patient. The caregiver must be able to participate in study procedures, specifically the text-messaging system. Both the VT and active control involve 8 weeks of once weekly visits and daily home exercises, and the investigators believe a caregiver would increase the likelihood of successful completion of either therapy. Exclusion Criteria: * Diagnosis of severe AD (CDR≥3). * Diagnosis of mild cognitive impairment or diagnosis of non-AD dementia, for example Parkinson's disease dementia, Dementia with Lewy Bodies, vascular dementia, fronto-temporal dementia, and primary progressive aphasia. * Deemed unable to participate in study procedures and VT or active control, (e.g. patients with significant medical comorbidities, excessive agitation, or use of mobility aids such as a cane or walker.) * Use of daily vestibular suppressant medications, specifically anti-histamines and benzodiazepines, as this can alter the response to VT. * Lack of availability to participate in 8 weeks of VT or active control.
Contact & Investigator
Yuri Agrawal, MD
PRINCIPAL INVESTIGATOR
Johns Hopkins University
Frequently Asked Questions
Who can join the NCT03799991 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Vestibular Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03799991 currently recruiting?
Yes, NCT03799991 is actively recruiting participants. Contact the research team at yagrawa1@jhmi.edu for enrollment information.
Where is the NCT03799991 trial being conducted?
This trial is being conducted at Baltimore, United States.
Who is sponsoring the NCT03799991 clinical trial?
NCT03799991 is sponsored by Johns Hopkins University. The principal investigator is Yuri Agrawal, MD at Johns Hopkins University. The trial plans to enroll 100 participants.